AB0901 Effects of Treatment with Risankizumab on Reducing Pain and Inflammation in Patients with Psoriatic Arthritis: An analysis of the KEEPsAKE -1 and -2 Trials
Authors: A. Ostor, S. Kwatra, C. Nduaka, M. Patel, A. M. Soliman, L. Barcomb, Z. Xue, H. Photowala, K. Papp
Journal: Annals of the Rheumatic Diseases (2022)

Background Risankizumab (RZB), a monoclonal antibody that specifically inhibits interleukin 23, is being investigated as a treatment for adults with psoriatic arthritis (PsA). Objectives Evaluate the efficacy of RZB treatment on the reduction in pain and inflammation in patients with active PsA Methods KEEPsAKE-1 and -2, double-blind, phase 3 trials, evaluated the efficacy of RZB versus placebo (PBO) for the treatment of adult patients with active PsA. Patients were randomized (1:1) to receive subcutaneous RZB 150 mg or PBO at weeks 0, 4, and 16. A reduction in pain visual analogue (VAS) score of 30% (meaningful), 50% (substantial) from baseline, and achievement of a minimal clinically important difference (MCID) in pain VAS was analyzed using NRI. High-sensitivity C reactive protein (hsCRP) was analyzed using mixed-effect model repeated measurement. Results are reported from the 24-week timepoint. Results A total of 1407 patients were included in the 24-week assessment (KEEPsAKE-1 RZB=483, PBO=481; KEEPsAKE-2 RZB=224, PBO=219). Patients receiving RZB achieved significantly higher levels of meaningful pain reduction than did patients receiving placebo (KEEPsAKE-1 54.7% vs 31.1%, P&lt;0.001; KEEPsAKE-2 43.3% vs 22.2%, P&lt;0.001). Similar trends were noted for substantial pain reduction (KEEPsAKE-1 37.7% vs 18.5%, P&lt;0.001; KEEPsAKE-2 31.9% vs 15.2%, P&lt;0.001). Patients receiving RZB were also significantly more likely to achieve a MCID than patients receiving PBO in both KEEPsAKE-1 (72.9% vs 56.2%, P&lt;0.001) and KEEPsAKE-2 (64.6% vs 46.0%, P&lt;0.001). A numerically greater reduction in hs-CRP was demonstrated in both studies for patients receiving RZB compared to PBO (KEEPsAKE-1 -4.32 vs -0.20; KEEPsAKE-2 -1.14 vs 0.25). Conclusion RZB treatment resulted in clinically meaningful improvements in pain and inflammation for patients with active PsA. Acknowledgements AbbVie funded the research for this study and provided writing support for this abstract. Medical writing assistance was provided by Trisha Rettig, Ph.D. of AbbVie Disclosure of Interests Andrew Ostor Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB., Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB., Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB., Shawn Kwatra Speakers bureau: Abbvie, Celldex Therapeutics, Galderma, Incyte Corporation, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Kiniksa Pharmaceuticals, Pfizer Inc., and Sanofi., Consultant of: Abbvie, Celldex Therapeutics, Galderma, Incyte Corporation, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Kiniksa Pharmaceuticals, Pfizer Inc., and Sanofi., Grant/research support from: Abbvie, Celldex Therapeutics, Galderma, Incyte Corporation, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Kiniksa Pharmaceuticals, Pfizer Inc., and Sanofi., Chudi Nduaka Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Manish Patel Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Ahmed M. Soliman Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Lisa Barcomb Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Zhenyi Xue Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Huzefa Photowala Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Kim Papp Speakers bureau: AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Evelo, Galapagos, Galderma, Genentech, Gilead, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, MedImmune, Meiji Selka Pharma Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, and UCB, Consultant of: AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Evelo, Galapagos, Galderma, Genentech, Gilead, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, MedImmune, Meiji Selka Pharma Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, and UCB, Grant/research support from: AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Evelo, Galapagos, Galderma, Genentech, Gilead, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, MedImmune, Meiji Selka Pharma Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, and UCB